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OpenTrials
Completed

NCT Number: NCT03163303

Smoking Tobacco and Drinking Study

This trial will test the efficacy of a 3-month intervention on Facebook targeting tobacco use and heavy episodic drinking against a 3-month Facebook intervention targeting tobacco use. Both groups will be offered a nicotine patch starter kit. The primary outcome is verified 7-day point prevalence abstinence from smoking at 3, 6, and 12 months.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Francisco Department of Psychiatry

San Francisco, California, 94143, United States

About this study

Participants will be randomized to one of two conditions: (1) a Facebook-delivered intervention addressing tobacco use and heavy episodic drinking, tailored to readiness to quit smoking; or (2) a 3-month Facebook intervention targeting tobacco use. Both interventions will include 12 weeks of Facebook-based messages and activities tailored to participants' readiness to quit smoking.

Assessments will occur at baseline, 3, 6, and 12 months follow-up. Assessments will include measures on smoking and drinking patterns and thoughts about abstinence. All participants who report no past 7-day smoking will be asked to give biochemical verification of smoking status with saliva cotinine test kits that will be mailed to participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • read English
  • between 18 and 25 years of age
  • indicate they use Facebook "most" (≥ 4) days per week
  • have smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
  • have had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

Exclusion criteria

  • do not read English
  • are not between 18 and 25 years of age
  • indicate they do not use Facebook "most" (≥ 4) days per week
  • have not smoked ≥100 cigarettes in their lives and currently smoke at least 1 cigarette per day on 4 or more days of the week
  • have not had at least one heavy drinking episode (5+ for men, 4+ for women) in the past month.

Treatment and study plan

Tobacco Status Project Intervention

Behavioral

90 days of Facebook messaging, weekly live sessions targeting tobacco use

Tobacco Status Project + Alcohol Intervention

Behavioral

90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use

Nicotine patch

Drug

14-day supply of nicotine patch

Primary outcomes

  1. Number of Participants With Reported 7-day Point Prevalence Abstinence at 3 Months

    Time frame: 3 months post baseline

    Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 3 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level <11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers

  2. Number of Participants With Reported 7-day Point Prevalence Abstinence at 6 Months

    Time frame: 6 months post baseline

    Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 6 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level <11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers

  3. Number of Participants With Reported 7-day Point Prevalence Abstinence at 12 Months

    Time frame: 12 months post baseline

    Point prevalent abstinence was defined as biochemically-verified reports of no smoking in the 7 days prior to the 12 month assessment. Participants reporting no smoking in the past 7 days will be coded as abstinent from cigarettes. Participants with a salivary cotinine level <11 ng/ml, indicating nonsmoking were considered confirmed nonsmokers

Secondary outcomes

  1. Number of Participants With a Reduction in Cigarettes Smoked Over Time

    Time frame: 3, 6, and 12 months post baseline

    A reduction was defined as the number of cigarettes smoked in past 7 days prior to the assessment by 50% or more compared to baseline number of cigarettes at 3, 6, and 12 month

  2. Number of Participants Whom Attempted to Quit Tobacco Use During the Course of Treatment

    Time frame: 3, 6, and 12 month post-baseline

    An attempt was defined by the participants response to the a question as to whether or not they had made an attempt to quit smoking during the course of treatment at the 3, 6, and 12 months post-baseline assessments. Participants who were determined to have made an attempt at least once during the entire course of treatment were scored as yes or no.

  3. Number of Participant Reporting a Readiness to Quit Tobacco Use Over Time

    Time frame: 3, 6, and 12 months post-baseline

    Readiness to change tobacco use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy smokers participating in brief intervention and the tobacco item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit smoking in next 30 days (or is already). Number of participants ready to change smoking in the next month assessed at 3, 6, and 12 months

  4. Average Score on the Thoughts About Abstinence Questionnaire (Smoking)

    Time frame: At Baseline

    The Thoughts About Abstinence Questionnaire (TAAS, (Hall et al., 1991) is a 3 item self-report questionnaire that measures: 1) desire to quit smoking, 2) expected success at quitting, 3) expected difficulty of quitting on 10-point Likert scales (e.g., 1=no desire to quit/lowest expectation/lowest level of difficulty to 10 = extreme desire to quit/highest expectation of success/highest expected difficulty) was assessed at baseline.

  5. Average Number of Days of Heavy Episodic Drinking (HED) Over Time

    Time frame: 3, 6, and 12 months post-baseline

    HED is defined as the number of days in the past month with 4+ drinks consumed in a a single occasion for women and 5+ drinks for men. HED was assessed at 3, 6 and 12 months.

  6. Median Number of Drinks Per Week Over Time

    Time frame: 3, 6, and 12 months post-baseline

    The number of drinks per week was defined as drinks per week in the past 30 days and assessed at the 3,6,and 12 month assessments.

  7. Average Score on the Alcohol Use Disorder Identification Test - Concise (AUDIT-C) Over Time

    Time frame: 3, 6, and 12 months post-baseline

    Misuse of alcohol in the past year was assessed by the AUDIT-C. The AUDIT-C is a brief alcohol screening instrument that reliably identifies persons who are hazardous drinkers or have active alcohol use disorders (including alcohol abuse or dependence) and consists of 3 questions with a total score ranging from 0-12, and generally the higher the score, the more likely it is that a person's drinking is affecting his or her safety. Each AUDIT-C question has 5 answer choices valued from 0 points to 4 points. In men, a score of 4 or more is considered positive, optimal for identifying hazardous drinking or active alcohol use disorders. In women, a score of 3 or more is considered positive. Participants were given this assessment at months 3, 6, and 12.

  8. Alcohol Quit Attempt

    Time frame: 3, 6, and 12 months post-baseline

    Follow-up Drinking Questionnaire will assess the presence and number of 24 hr quit attempts since the last assessment. This assessment will be used to calculate presence of at least one quit attempt in the assessment time period and scored as a yes or no.

  9. Readiness to Change Alcohol Use Over Time

    Time frame: 3, 6, and 12 months post-baseline

    Readiness to change alcohol use will be assessed with a single-item Readiness Ruler, developed and validated for use with young adult heavy drinkers participating in brief intervention and the alcohol item from the Staging Health Risk Assessment (S-HRA) to compare stage of change across tobacco and alcohol use. Plans to limit drinking in next 30 days (or is already) Proportion of participants ready to change drinking in the next month assessed at 3, 6, and 12 months

  10. Average Score on the Thoughts About Abstinence Questionnaire (Heavy Episodic Drinking) Over Time

    Time frame: 3, 6, and 12 months post-baseline

    The Thoughts About Abstinence Questionnaire (TAAS, (Hall et al., 1991) is a 4 item self-report questionnaire that measures: 1) desire to quit heavy episodic drinking, 2) expected success at quitting, 3) expected difficulty of quitting, and 4) confidence in ability to quit on 10-point Likert scales (e.g., 1=no desire to quit; 10 = extremely ...adapted for heavy episodic alcohol use

  11. Number of Participants With Reported Combined Use Using Tobacco or Alcohol Over Time

    Time frame: 3, 6, and 12 months post-baseline

    Timeline Follow-back data will be used to calculate the sum of days using any tobacco or binge drinking in the past month.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Using Facebook to Address Smoking and Heavy Drinking in Young Adults

Acronym: STAND

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 23, 2017
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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